EUCTR2015-001922-40-BE进行中（未招募）1 期
An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
- •Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- •Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- •Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •Patient has been permanently discontinued from ceritinib study
- •treatment in the parent study due to any reason.
- •Patient currently has unresolved toxicities for which ceritinib dosing
- •has been interrupted in the parent study. (Patients meeting all other
- •eligibility criteria may be enrolled once toxicities have resolved to allow
- •ceritinib dosing to resume.)
- •Pregnant or nursing (lactating) women, where pregnancy is defined
- •as the state of a female after conception and until the termination of
- •gestation, confirmed by a positive serum hCG laboratory test.
- •Women of child-bearing potential, defined as all women
- •physiologically capable of becoming pregnant, unless they are using
- •highly effective methods of contraception.
- •Sexually active males unless they use a condom during intercourse
- •while taking drug and after stopping ceritinib and should not father a
- •child in this period.
- •Other protocol defined exclusion criteria may apply.
研究者
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